Design controls designates the application of a formal
methodology
In its most common sense, methodology is the study of research methods. However, the term can also refer to the methods themselves or to the philosophical discussion of associated background assumptions. A method is a structured procedure for br ...
to the conduct of
product development
In business and engineering, new product development (NPD) covers the complete process of bringing a new product to market, renewing an existing product or introducing a product in a new market. A central aspect of NPD is product design, along w ...
activities.
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g.
medical devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
).
Medical devices
Since 1990, the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) has required that
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:
*
Design and development planning
*
Design input, including intended use and
user needs (also known as customer attributes)
*
Design output, including evaluation of conformance to design input requirements through:
** Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
** Design validation ensuring that the devices conform to defined user needs and intended uses ("did we design the right device?")
*
Design review
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-p ...
*
Design transfer ensuring that the device design is correctly translated into production specifications
*
Design changes
*
Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
The
Medical Devices Directive
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a ' ...
(MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The
Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device.
ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive ...
is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of
efficacy and safety.
Design input
Examples of design input:
References and external links
* 21 CFR 820.30 on the FDA websit
* MDD 93/42/EE
References
{{DEFAULTSORT:Design Controls
Design
Food and Drug Administration
Regulation of medical devices